3 results
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
Primary objective: Estimate the MTD and/or RDE of LDK378 as a single agent when administered orally to pediatric patients with ALK-activated tumors in the fasted and in fed stateSecondary objectives: Objective 1: Characterize the safety and…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…